10 results
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35ms
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Sources: EU EUDAMED, US FDA
GIP/MEDI-GLOBE BIOPSY FORCEPS
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
Medline UNITE® MIS Foot Recon Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
BODY CLOCK STIMPLUS AND STIMPLUS PRO
FDA 510(k)
FDA Class 2
·Neurology
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 31, 2013
M SERIES
FDA Adverse Event
ZOLL MEDICAL CORP.·Product code MKJ·December 20, 2010
BATT-HANDPIECE MOD F/TRS
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code GEY·July 17, 2014
UNKNOWN
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code FGE·September 14, 2018
HARMONY DELIVERY CATHETER SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NPV·February 13, 2026
Model ST-400 Solafeet Foot portable tanners; Solafeet, Inc. Use: feet tanner.
FDA Recall
Terminated
·Solafeet, Inc.·Product code REG·September 8, 2009
Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013